Capella Scientia Development Study

NCT06987474 | Recruiting

• 1 other identifier: CTK378-E006
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 4

Brief Summary

This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Manifest Refraction Spherical Equivalent (MRSE)

  A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent is calculated by adding the sum of the sphere power with half of the cylinder power. MRSE will be reported in diopters.

  Group 1 and Group 4: Day 0; Group 2 and Group 3: Screening (Day -30 to Day -1), Day 30 to 60 postoperative, Day 70 to 100 postoperative

Study Arms (4)

Group 1

Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer

Group 2

Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer

Group 3

Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer

Group 4

Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer

Interventions

Unity DX and SMARTCataract DX (SCDX) Biometer DEVICE

Unity DX is a CE-marked, noninvasive, noncontact instrument that generates a 3D model of the eye using hyper parallel optical coherence tomography (HP OCT), aberrometry, and topography. The current version of SCDX software will be used in this study.

Group 1; Group 2; Group 3; Group 4

IOLMaster 700 Biometer DEVICE

The IOLMaster 700 Biometer is a CE-marked, noninvasive, noncontact instrument that captures optical biometry. Data will be collected using standard clinical assessments.

Group 1; Group 2; Group 3; Group 4

Argos with Alcon Image Guidance Biometer DEVICE

The Argos with Alcon Image Guidance biometer is a CE-marked, noninvasive, noncontact instrument that will capture optical biometry. Data will be collected using standard clinical assessments.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical sites located in India, Spain, and the Philippines.

You may qualify if:

• Able to understand and sign an IRB/IEC approved consent form;
• Willing and able to attend study visit(s) as required by the protocol;
• Consenting age at the jurisdiction of study site;

You may not qualify if:

• Women of child-bearing potential;
• Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
• Unclear optical media preventing data capture from all devices in the study;
• Contraindicated for pupil dilation (e.g., narrow angles, allergies) per investigator's clinical judgment;
• Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Narayana Nethralaya

Bangalore, 560010, India

NOT YET RECRUITING

Asian Eye Institute

Makati City, 1200, Philippines

RECRUITING

Clinica Novovision - Clinica Madrid

Madrid, 28046, Spain

RECRUITING

Clinica Rementeria

Madrid, 28101, Spain

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Principal II, Clinical Trial Operations, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937; alcon.medinfo@alcon.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); ES (2); IN (1)